Background:Although the treatment of peripheral T-cell lymphoma(PTCL)has undergone advancements during the past several years,the response rate and long-term effects with respect to patients with PTCL remain unsatisfactory—particularly for relapsed or refractory(R/R)patients.This phase II trial was designed to explore the efficacy and safety of an all-oral regimen of chidamide plus prednisone,cyclophosphamide,and thalidomide(CPCT)for R/R PTCL patients who could not tolerate the standard chemotherapy for a variety of reasons.Methods:We conducted a multicenter phase II clinical trial in which we combined chidamide(30 mg twice weekly)with prednisone(20 mg daily after breakfast),cyclophosphamide(50 mg daily after lunch),and thalidomide(100 mg daily at bedtime)(the CPCT regimen)for a total of fewer than 12 cycles as an induction-combined treatment period,and then applied chidamide as single-drug maintenance.Forty-five patients were ultimately enrolled from August 2016 to April 2021 with respect to Chinese patients at nine centers.Our primary objective was to assess the overall response rate(ORR)after the treatment with CPCT.Results:Of the 45 enrolled patients,the optimal ORR and complete response(CR)/CR unconfirmed(CRu)were 71.1%(32/45)and 28.9%(13/45),respectively,and after a median follow-up period of 56 months,the median progression-free survival(PFS)and overall survival(OS)were 8.5 months and 17.2 months,respectively.The five-year PFS and OS rates were 21.2%(95%confidence interval[CI],7.9-34.5%)and 43.8%(95%CI,28.3-59.3%),respectively.The most common adverse event was neutropenia(20/45,44.4%),but we observed no treatment-related death.Conclusion:The all-oral CPCT regimen was an effective and safe regimen for R/R PTCL patients who could not tolerate standard chemotherapy for various reasons.Trial Registration:ClinicalTrials.gov,NCT02879526.
Jinhua Liang;Li Wang;Xiaodong Wang;Guohui Cui;Jianfeng Zhou;Tongyao Xing;Kaixin Du;Jingyan Xu;Luqun Wang;Rong Liang;Biyun Chen;Jian Cheng;Haorui Shen;Jianyong Li;Wei Xu;
Department of Hematology,The First Affiliated Hospital of Nanjing Medical University,Jiangsu Province Hospital,Nanjing,Jiangsu 210029,China Key Laboratory of Hematology of Nanjing Medical University,Nanjing,Jiangsu 210029,China Collaborative Innovation Center for Cancer Personalized Medicine,Nanjing,Jiangsu 210029,ChinaDepartment of Hematology,Sichuan Academy of Medical Sciences&Sichuan Provincial People’s Hospital,School of Medicine of University of Electronic Science and Technology of China,Chengdu,Sichuan 610000,ChinaDepartment of Hematology,Union Hospital,Tongji Medical College,Huazhong University of Science and Technology,Wuhan,Hubei 430022,ChinaDepartment of Hematology,Tongji Hospital,Tongji Medical College,Huazhong University of Science and Technology,Wuhan,Hubei 430030,ChinaDepartment of Hematology,Nanjing Drum Tower Hospital,Nanjing University Medical School,Nanjing,Jiangsu 210008,ChinaDepartment of Hematology,Qilu Hospital of Shandong University,Jinan,Shandong 250000,ChinaDepartment of Hematology,Xijing Hospital,The Fourth Military Medical University,Xi’an,Shaanxi 710032,ChinaDepartment of Hematology,Fujian Provincial Hospital,Fuzhou,Fujian 350001,ChinaDepartment of Hematology,Zhongda Hospital,Medical School of Southeast University,Nanjing,Jiangsu 210009,China
临床医学
Peripheral T-cell lymphoma;Chidamide;Prednisone;Cyclophosphamide;Thalidomide;All-oral regimen
《Chinese Medical Journal》 2024 (013)
P.1576-1582 / 7
National Natural Science Foundation of China(Nos.81770166,81700193,82170186,and 81720108002);Jiangsu Province’s Medical Elite Programme(No.ZDRCA2016022);Project of the National Key Clinical Specialty,the Jiangsu Provincial Special Program of Medical Science(No.BE2017751);National Science and Technology Major Project(No.2018ZX09734007);China Postdoctoral Science Foundation(No.2021M691336);Jiangsu Postdoctoral Science Foundation(No.2021K083A)
10.1097/CM9.0000000000002836
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